FDA 510(k)

CATHTONG II PICC 导管

K号: K170486 · 2017-05-25

决定日期2017-05-25

产品代码LJS

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

CATHTONG II PICC Catheter is the device name listed in this FDA 510(k) record. The listed applicant is L&Z Us, Inc.. It received FDA 510(k) clearance on 2017-05-25 under 510(k) number K170486. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CATHTONG II PICC Catheter?

CATHTONG II PICC Catheter is a medical device that received FDA 510(k) clearance on 2017-05-25. The listed applicant is L&Z Us, Inc.. The 510(k) number is K170486.

When did CATHTONG II PICC Catheter receive FDA 510(k) clearance?

CATHTONG II PICC Catheter received FDA 510(k) clearance on 2017-05-25, under 510(k) number K170486.

Who is the listed applicant for CATHTONG II PICC Catheter?

The FDA 510(k) record lists L&Z Us, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CATHTONG II PICC Catheter?

The FDA product code for CATHTONG II PICC Catheter is LJS.

列明L&Z Us, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K233149CATHTONG III 锥形 PICC 导管 K232571CATHTONG™ II PICC 导管 K232594CATHTONG™ II PICC 导管 K172039CATHTONG II PICC 导管 K153469Cathtong I PICC Catheter

相关器械（代码：LJS）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K260929Neonav ECG 插针定位系统Navi Medical Technologies K252373BioFlo 混合 PICC 配有 ENDEXO 技术和 PASV 阀技术；BioFlo PICC 配有 ENDEXO 技术和 PASV 阀技术；BioFlo PICC 配有 ENDEXO 技术；BioFlo 中线导管；Xcela 注射式 PICC；Xcela PICC 配有 PASV 阀技术；Xcela 混合 PICC 配有 PASV 阀技术Spectrum Vascular K252792PM2®系统及ECGuide®连接器Piccolo Medical, Inc.K243458HydroPICC 4Fr 单腔标记导管，130 cm 导丝 - 基础套装 (70001301)；HydroPICC 4Fr 单腔标记导管，70 cm 导丝 - 基础套装 (70001302)；HydroPICC 4Fr 单腔标记导管 - 最大屏障套装 (70001304)；HydroPICC 5Fr 双腔标记导管，130 cm 导丝 - 基础套装 (70002301)；HydroPICC 5Fr 双腔标记导管，70 cm 导丝 - 基础套装 (70002302)；HydroPICC 5Fr 双腔标记导管 - 最大屏障套装 (70002304)；HydrAccess Vascular, Inc.K251212双腔5Fr HydroPICC导管（PICC-251CM）（PICC-251CM）；双腔5Fr HydroPICC导管（PICC-252CM）（PICC-252CM）Access Vascular, Inc.K243484PM2+系统及SmartPICC导管Piccolo Medical, Inc.

官方来源

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